Remote Gene-Based Therapy CMC Consultant

Kikiktagruk Inupiat Corporation; United States Virgin Islands; Teletrabalho; USD 138 000 - 207 000; Tempo parcial

Resumo da oferta

Kikiktagruk Inupiat Corporation seeks a senior Gene-Based Therapy Product Development Consultant specializing in oligonucleotide CMC to support NIH programs. The role is remote and part-time, collaborating with cross-functional teams on IND-enabling activities and clinical evaluation strategies.

Candidates bring 10+ years in oligonucleotide therapy, leadership experience, and familiarity with FDA expectations.

Qualificações

• MS/PhD/MD preferred; PhD-level experience in biopharmaceutical industry required if BS/MS.
• At least 10 years of relevant professional experience in oligonucleotide therapy development.
• Experience leading multi-disciplinary teams and engaging with regulatory authorities.

Responsabilidades

• Provide senior-level CMC support for gene-based and oligonucleotide therapies across discovery to IND-enabling activities.
• Lead and collaborate with NIH LDTs/MPTs, mapping development milestones and overseeing CMOs/CDMOs and CROs.
• Drive strategic advisory input, maintain timelines, and ensure high-quality technical recommendations.
• Coordinate cross-functional workstreams in a virtual team environment and manage competing priorities.
• Demonstrate strong writing, communication, and documentation skills and broad biologics experience.

Conhecimentos

Senior leadership

Oligonucleotide/siRNA therapy

Regulatory interactions

Biopharmaceutical industry experience

Formação académica

MS/PhD/MD preferred

PhD-level experience in biopharmaceutical industry

Descrição da oferta de emprego

Kikiktagruk Inupiat Corporation seeks a senior Gene-Based Therapy Product Development Consultant specializing in oligonucleotide CMC to support NIH programs. The role is remote and part-time, collaborating with cross-functional teams on IND-enabling activities and clinical evaluation strategies.

Candidates bring 10+ years in oligonucleotide therapy, leadership experience, and familiarity with FDA expectations.